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Hematology Analysis Kit - EUDAMED Registration 06977254770062

Access comprehensive regulatory information for Hematology Analysis Kit in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 06977254770062 and manufactured by Shenzhen Hailife Biotechnology Co., Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Agencia Española de Medicamentos y Productos Sanitarios), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class A
06977254770062
No
Hematology Analysis Kit
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0103010105
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06977254770062
Basic UDI
697725477R1005HC
Version Date
September 12, 2024
Manufacturer Last Update
June 24, 2024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.22 Jinxiu Road Shenzhen
Email
linpei@hailife.com.cn
Authorized Representative
SRN
ES-AR-000019366
Country
Spain
Address
CARRER DE TAPIOLES, 33, 2- 1 Barcelona
Email
rep@themedunion.com
Telephone
+34644173535
Regulatory Information
Competent Authority
Agencia Española de Medicamentos y Productos Sanitarios
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Italy
Device Characteristics
Human Tissues
No
Animal Tissues
No